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The Simplant® Digital Guide is a surgical guide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Locite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.

The Simplant® Digital Guide is intended for use in assisting placement of dental implants. The subject Simplant® Digital Guide is a patient specific surgical template, which is designed according to the digital pre-operative plan of the dental implant positions. The clinician, or dental lab, orders a digital design file of the surgical quide (i.e. Simplant® Guide File) which is developed under the same process that is utilized to produce the design of the predicate Simplant® Guide (K170849). The subject Simplant® Digital Guide is then fabricated locally by the clinician or dental lab, utilizing stereolithography fabrication method. The subject Simplant® Digital Guide is intended to be fabricated using Dental SG acrylic resin, Form 2 SLA 3D printer, and FormWash and FormCure washing and post-curing equipment manufactured by Formlabs, Inc. The Simplant® Digital Guide sits on the patient's oral anatomy, i.e. teeth, mucosa or combination thereof. Aided by the Simplant® Digital Guide, the implant sites can be prepared, and the dental implants can be placed in the predetermined locations according to the previously pre-operative dental implant treatment plan.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Simplant® Digital Guide.

Here's an analysis of the provided information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported device performance in a single, clear format. Instead, the acceptance criteria are embedded within the descriptions of the non-clinical performance tests. The "reported device performance" is generally stated as "ensures that the subject device complies with" or "withstands," implying successful completion without providing specific metrics or thresholds within this summary.

Based on the text, here's a reconstructed table:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: For process validation of additive manufacturing, "at least 3 build runs" were used. More specific sample sizes for individual bench tests (e.g., number of guides for push-out, torque, deviation tests) are not explicitly provided in the summary.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given these are non-clinical bench tests, the concept of retrospective/prospective human data doesn't apply directly.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The studies described are non-clinical bench tests focused on physical and material properties, manufacturing accuracy, and sterilization efficacy, which do not involve expert interpretation or ground truth establishment in the clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. As the studies are non-clinical bench tests, there is no adjudication method for a test set by human experts. The compliance is determined by measurements against predefined engineering specifications and international standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. The device is a surgical guide, not an AI-assisted diagnostic or interpretative tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable in the context of an algorithm's performance. The device itself (Simplant® Digital Guide) is a physical surgical guide. Its performance is evaluated through bench testing against manufacturing specifications and industry standards. The "standalone" performance here refers to the device's inherent physical properties and manufacturing accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests is based on:

• Pre-operative Plan: For angulation, position, and vertical fit deviation tests, the pre-operative digital plan serves as the ground truth against which the manufactured guide's accuracy is measured.
• International Standards: For strength and biocompatibility, the ground truth is defined by established international standards (e.g., ISO 20795-1:2013-1, ISO 10993-1:2009, ISO 7405:2008, ISO 17665-1:2006, ISO 17665-2:2009).
• Engineering Specifications: For tube fixation (push-out and torque), the ground truth refers to internal engineering specifications for typical and occasional loads the device should withstand.

8. The sample size for the training set

This is not applicable. The Simplant® Digital Guide is a physical surgical guide manufactured using a specific process. There is no "training set" in the machine learning sense for this type of device. The manufacturing process itself is validated.

9. How the ground truth for the training set was established

This is not applicable as there is no training set mentioned or implied for this device.

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CEREC Guides are intended to support the dentist or oral surgeon when drilling for placement of dental implants. CEREC Guides are intended to be designed and fabricated using the Sirona Dental CAD/CAM System's CEREC Chairside software and CAM equipment, Galileos Implant dental implant planning software, and Calibra Universal Self-Adhesive Resin Cement.

The CEREC Guide dental surgical guides are milled poly(methyl methacrylate) [PMMA] devices which are designed and fabricated utilizing the Sirona Dental CAD/CAM System with CEREC Chairside Software (K181520) and are intended to act only as dental implant placement templates. The CEREC Guides are designed in the Sirona Dental CAD/CAM System's CEREC Chairside Software utilizing, as an input, a completed dental implant treatment plan which is developed in the "Galileos Implant treatment planning software as cleared under premarket notification K093090.

The CEREC Guide surgical guides are offered in two variants, the CEREC Guide 2 and CEREC Guide 3. Both the CEREC Guide 2 and CEREC Guide 3 are milled from the CEREC Guide Bloc milling blocks. The CEREC Guide Blocs are clear, PMMA blocks intended for milling utilizing the CEREC MC XL family of milling units. CEREC Guide Blocs are offered in two size variants, "medi" and "maxi".

The CEREC Guide 2 surgical guides consist of the surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. The CEREC Guide 2 surgical guides are used in conjunction with CEREC Guide Drill Keys. CEREC Guide Drill Keys are stainless steel, reusable drill guide instruments which are offered in variants with internal diameters ranging from 2.0 mm to 4.85 mm.

The CEREC Guide 3 surgical guides consist of the CAD/CAM surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. CEREC Guide 3 surgical guides feature integral titanium guide sleeves that are bonded the CEREC Guide 3 surgical guide body using Dentsply Sirona Calibra® Universal adhesive (K073173). The CEREC Guide 3 Guide Sleeves are single use and are offered in 4 size variants, with outer diameters ranging from 5.5 mm to 6.0 mm, and internal diameters ranging from 4.48 mm - 5.2 mm.

The provided FDA 510(k) premarket notification for "CEREC Guides" focuses on demonstrating substantial equivalence to a predicate device ("SIMPLANT Guide," K170849) through non-clinical performance data. It does not involve a multi-reader multi-case (MRMC) study or artificial intelligence (AI) performance evaluation. Therefore, many of the requested elements for an AI-based device, such as ground truth establishment by experts, adjudication methods, and MRMC study details, are not applicable here.

Here's a breakdown of the available information relevant to acceptance criteria and study proving device performance:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with specific numerical thresholds and corresponding performance results in the format requested, typical for AI/ML device submissions. Instead, it describes various non-clinical tests conducted to support substantial equivalence. The "acceptance criteria" are implied by the successful completion of these validation tests.

2. Sample size used for the test set and the data provenance

The document describes non-clinical bench and validation tests rather than a test set of patient data. Specific sample sizes for these engineering and material tests (e.g., number of guides milled for accuracy, number of drill sleeves tested for retention) are not detailed in this summary. The data provenance is from the manufacturer's internal testing as part of the regulatory submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on non-clinical engineering and performance testing, not on interpretative performance (like image reading) where expert ground truth is typically established. The "ground truth" for the device's function is its design specifications and physical properties, tested through controlled experiments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There's no human adjudication process described, as it's not a study evaluating human interpretation or AI output against a consensus.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device, CEREC Guides, is a physical, milled surgical guide, not an AI or software-assisted diagnostic tool that would typically undergo an MRMC study to assess reader performance. The submission explicitly states: "No human clinical data was included in this premarket notification to support the substantial equivalence of the subject CEREC Guides."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. Its performance is evaluated based on its physical properties, manufacturing accuracy, and integration with existing approved software and hardware. The "device" itself is the physical CEREC Guide.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests is based on:

• Design Specifications and Reference Standards: The intended design dimensions and functionalities derived from the Galileos Implant treatment planning software served as the reference for accuracy testing.
• Established Material Properties and Biocompatibility Standards: ISO standards (e.g., ISO 10477, ISO 10993-1) and published literature for material strength and biocompatibility served as the benchmark.
• Validated Disinfection Protocols: FDA and industry guidelines for high-level disinfection processes.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment for a training set.

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The SIMPLANT® Guide is intended for use in assisting placement of dental implants.

The SIMPLANT® Guide is intended for use in assisting placement of dental implants.

It is a patient specific surgical template that is produced based upon knowledge of the location and orientation of the implant(s) prior to the surgery.

The design of the SIMPLANT® Guide is made according to the clinician's plan of the implant positions. The final guide is fabricated from an epoxy resin using computerassisted manufacturing to produce a patient specific device.

The SIMPLANT® Guide sits on the patient's oral anatomy, i.e. teeth, mucosa, bone or a combination thereof. Aided by the SIMPLANT® Guide, the implant sites can be prepared and the dental implants placed in the predetermined locations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SIMPLANT® Guide:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical thresholds in the provided document. Instead, the document indicates that the SIMPLANT® Guide meets the same acceptance criteria as its predicate device (SurgiGuide® guide). The "Results" column for the proposed SIMPLANT® Guide consistently reports "PASS", indicating it successfully met these unstated criteria.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each "bench test." It mentions "non-clinical performance tests have been developed in-house" and "were executed to demonstrate substantial equivalence."

The data provenance is internal/in-house bench testing with no mention of country of origin of the data or whether it was retrospective or prospective in the context of human data. Given it's bench testing, it's a prospective series of tests conducted on the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. For bench testing, "ground truth" typically refers to engineering specifications, measurement standards, or the performance of a validated predicate device. The document states that the performance meets the "same acceptance criteria" as the predicate, implying the predicate's performance served as the benchmark.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of bench testing, the adjudication would likely be based on objective measurements and adherence to predefined test protocols and acceptance criteria, rather than a consensus method among human experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not conducted or described for the SIMPLANT® Guide. The device is a surgical guide, not an AI-powered diagnostic or assistive tool for human readers/clinicians in the way typically assessed by MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not directly applicable to the SIMPLANT® Guide in the context of typical AI algorithm performance. The SIMPLANT® Guide is a physical surgical template produced using computer-assisted manufacturing based on a clinician's plan. While "algorithm" might be involved in the manufacturing process (CAD/CAM), the device itself is a physical tool, not a standalone algorithm. The "standalone performance" in this context would be its physical accuracy and durability, which were tested via the bench tests (Tube Fixation, Bending, Angulation, Position, Vertical Fit).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench tests, the ground truth or reference point appears to be:

• Engineering Specifications/Pre-operative Plan: For the Angulation Deviation, Position Deviation, and Vertical Fit Tests, the "ground truth" is the device's design and how closely the manufactured product adheres to it.
• Predicate Device Performance: The primary comparative "ground truth" is that the new device must meet the "same acceptance criteria" and perform identically to the predicate SurgiGuide® guide under the specified test conditions. This implies that the predicate's established performance serves as the benchmark for "acceptable" over typically applied loads.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The SIMPLANT® Guide is a manufactured surgical template, not an AI model that requires a training set. The "design" (which might involve software or CAD) is based on the clinician's pre-operative implant plan, not a learned model from a large dataset.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/not provided for the same reasons as point 8.

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SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.

SPI® VECTOdrill™ ceramic drills are reusable zirconia dental implant drill bits for use with the SPI Dental Implant System. SPI VECTOdrill ceramic drills include a pilot drill and three progressive twist drills. The pilot drill has a sler, highly efficient tip that initiates the pilot hole without the need for a round bur. The pilot drill also has the ability to cut laterally, in order to allow slight axial correction. The twist drills do not cut laterally, which helps to avoid enlarging the diameter of the osteotomy site. Each twist drill has an integrated guide at the tip, which is the same diameter as the preceding drill, in order to provide automatic axial quidance.

The pilot drill has a diameter of 2.0 mm and is available in 29.0 mm and 34.0 mm lengths. The twist drill is available in three diameters (2.8 mm, 3.5 mm and 4.3 mm) and two lengths for each diameter (29.0 mm and 34.0 mm).

Both the pilot drill and the twist drill have the proximal end configured to fit into a dental handpiece latch. All SPI VECTOdrills have a length 0.5 mm longer than the corresponding SPI Dental Implants. Each drill has depth markings that correspond to the VECTOdrill depth gauge in increments of 1.5 mm, from 8.0 mm to 17.0 mm. SPI VECTOdrill ceramic drills are intended to be resterilized and reused up to 20 times.

SPI VECTOdrill ceramic drills are made of alumina toughened zirconia (ATZ). SPI VECTOdrill ceramic drills are packed individually in a transparent plastic tube contained in a sealed plastic sleeve and are provided non-sterile.

Testing of SPI VECTOdrill ceramic drills established their ability to retain their cutting ability under aggressive cutting conditions. Testing also resulted in the conclusion that the mechanical properties of SPI VECTOdrill ceramic drills are appropriate for their safe use.

Here's an analysis of the provided information regarding the acceptance criteria and study for the SPI® VECTOdrill™ Ceramic Drills:

Crucially, the provided document does not contain detailed information about specific acceptance criteria, a formal study protocol, or quantitative performance metrics typically found in a comprehensive medical device validation study report.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full performance validation report. Therefore, many of the requested sections will state "Not provided" or explain that the information is not present in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific quantitative acceptance criteria are not explicitly stated in this 510(k) summary. The summary broadly states that "Testing... established their ability to retain their cutting ability under aggressive cutting conditions" and "resulted in the conclusion that the mechanical properties... are appropriate for their safe use." Without specific metrics (e.g., minimum cutting efficiency, maximum wear per use, fracture strength thresholds), it's impossible to create a table with numerical acceptance criteria and corresponding reported performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "Testing of SPI VECTOdrill ceramic drills" but does not give a number of drills tested or the extent of the testing.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. Given the manufacturer is Thommen Medical AG (Switzerland) and the representative is in the USA, the testing could have occurred in either region, or elsewhere. The nature of the testing (bench testing for mechanical properties and cutting ability) suggests it was likely prospective, but this is not confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This type of information is generally not applicable to a device like a dental drill. Ground truth for a drill's performance would typically be based on objective physical measurements (e.g., torque, force, wear, cutting depth, material analysis) rather than expert interpretation of images or clinical outcomes. Therefore, no experts would be needed to establish "ground truth" in the way described for diagnostic devices.

4. Adjudication Method for the Test Set

• Not applicable, as ground truth typically refers to clinical or diagnostic assessment, not objective mechanical property testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, often with AI assistance. The SPI® VECTOdrill™ Ceramic Drills are surgical instruments, and their performance is assessed through mechanical and material testing, not through human reader interpretation. There is no AI component mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical surgical instrument, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is irrelevant. The performance of the drill itself, without a human operator, cannot be meaningfully assessed, as its function inherently requires human use.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For this device, the "ground truth" would be established through objective, standardized engineering and material science testing. This would involve:
  • Mechanical Property Testing: Measuring tensile strength, bending strength, hardness, fracture toughness, etc., against predefined material specifications.
  • Cutting Performance Testing: Assessing cutting speed, efficiency, and wear under simulated clinical conditions (e.g., drilling into bone substitutes).
  • Durability/Fatigue Testing: Simulating repeated sterilization and use to evaluate structural integrity and performance over its intended lifespan (up to 20 uses).
  • Visual Inspection/Metrology: Checking for physical defects, dimensions, and tolerances.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI model, this question does not apply.

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